The Fees for Fiscal Year 2016 (October 1, 2015 through September 30, 2016) are as follows:
FY16 User Fees (in U.S. Dollars)
|Application Type||Standard Fee||Small Business Fee†|
|PMA, PDP, PMR, BLA||$261,388||$65,347|
|BLA efficacy supplement||$261,388||$65,347|
|PMA annual report||$9,149||$2,287|
‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Annual Establishment Registration Fee: $3,845
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
Additional Information about MDUFA III Fees
FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments(PDF - 317KB)
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2016
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)